Kornimate/medical-research-clean huggingface dataset:
pharmacofmri (functional magnetic resonance imaging) of anxiolytic medications (alprazolam)

Conditions: Anxiety Disorders

Summary: the purpose of this study is to use functional magnetic resonance imaging (fmri) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.

increased amygdala and insula activity have been implicated in neurobiological models of anxiety. using fmri, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. this study aims to replicate those results but by using a different medication, alprazolam. an eventual aim of this study, in combination with future studies, is to evaluate the utility of fmri as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Eligibility criteria:
inclusion criteria: * male, or female (not pregnant or intending to become pregnant during the study) * between the ages of 18-30. * in good general health. * no specific contraindications to the drug being administered exclusion criteria: * subjects with a history of dsm-iv depressive disorder, psychotic disorder, anxiety disorder * subjects who meet criteria for substance abuse or dependence within the last 6 months * subjects with an positive urine screen for illicit drugs * having clinically significant abnormal laboratory, ecg or physical examination findings not resolved by the baseline visit * patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, maoi's) within the last year * subject is left-handed. * the subject suffers from claustrophobia, or phobia for injections or blood. * magnetic resonance imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an i.u.d. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit).

Keywords: functional magnetic resonance imaging fmri alprazolam anxiety disorders
internet-based parent training for parents of children with externalising behavior problems

Conditions: Behavior Problem; Parenting

Summary: the study aims to evaluate the efficacy of a 5-week, therapist-guided, internet-delivered parent management training program (bip samba) targeting children aged 5 - 11 years with externalising behavior problems. the study is a randomised controlled trial with parents of n=30 children participating. the intervention bip samba is compared with a waitlist control condition. participants in the control condition will be crossed over to the active treatment after 5 weeks. the primary outcome measure is the eyberg child behavior inventory (ecbi) at the post treatment (5 weeks after baseline assessment).


Eligibility criteria:
inclusion criteria: * being parent of a child between 5 and 11 years * this child has externalising behavior problems * the parent has access to the internet * the parent speaks and write swedish exclusion criteria: * the child has an autism diagnosis * the child has severe conduct problems * there is domestic violence occurring within the family * there alcohol or substance abuse occurring within the family
efficacy of opioid-free anesthesia in reducing postoperative respiratory depression in children undergoing tonsillectomy

Conditions: Anesthesia; General Anesthesia; Analgesics, Opioid; Postoperative Complications; Pathologic Processes; Physiologic Effects of Drugs; Narcotics; Analgesics; Sleep Disordered Breathing; Obstructive Sleep Apnea of Child; Tonsillectomy; Respiratory Depression; Dexmedetomidine; Ketamine; Lidocaine; Gabapentin; Pulse Oximetry

Summary: the objective of this trial is to determine whether an opioid-free general anesthetic (ofa) technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques. it is expected that this ofa regimen will have a measurable reduction on postoperative respiratory depression in children with sleep-disordered breathing.

the objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques.

Eligibility criteria:
inclusion criteria: * patients aged 0-12 years with sleep disordered breathing (sdb) who are scheduled for elective tonsillectomy/adenotonsillectomy (t/at) will be recruited at royal university hospital, saskatoon, saskatchewan. exclusion criteria: * age \> 12; american society of anesthesiologists (asa) classification \> iv; significant cardiorespiratory, neurological, craniofacial, hepatic, renal, or genetic disorders, excluding sdb; concomitant surgical procedures other than myringotomy and tubes; and allergy to any of the study drugs

Keywords: opioid-sparing opioid-free
to evaluate the efficacy and safety of multifocal soft contact lens in myopia control

Conditions: Myopia

Summary: the objective of this study is to investigate the efficacy and safety of soft lens in myopia control.

this is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "soft lens" in myopia control among schoolchildren. a total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. a total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. subjects will be encouraged to complete all planned visits.

Eligibility criteria:
inclusion criteria: 1. both genders aged between 6 and 15 years 2. spherical equivalent refractive error between -1.00d and -10.00d 3. visual acuity with contact lens of 20/25 or better in each eye 4. astigmatism less than or equal to 1.50d 5. anisometropia less than or equal to 1.00d 6. agree to wear assigned contact lens and able to comply with the study protocol 7. subjects and/or their legal representatives agree to sign informed consent form exclusion criteria: 1. eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example: 1. amblyopia 2. severe strabismus at investigator's discretion 3. pathologically dry eye 4. aphakia 5. slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1 6. currently ocular infection of any type or inflammation in either eye 7. oculomotor nerve palsies 8. pupil or lid abnormality in either eye 9. severe ocular allergy 10. anterior segment infection, inflammation or abnormality 11. corneal vascularization greater than 1 mm of penetration 12. history of herpetic keratitis 2. use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit 3. systemic disease that may affect vision or contact lens wearing (e.g. diabetes, down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver 4. surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery) 5. receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), prednisolone or ritalin (methyphenidate)

Keywords: myopia control
metformin for the treatment of nonalcoholic fatty liver disease (nafld)

Conditions: Fatty Liver

Summary: the purpose of this study is to find out if metformin is safe and useful in the treatment of nafld.

nafld is a poorly understood disease which may cause an enlarged liver, abnormal liver test results, and scarring of the liver. it may occur more often in people with obesity, high levels of cholesterol (blood fats), diabetes (high blood sugar), or the insulin resistance syndrome (where a person's body does not respond to the hormone insulin which helps keep blood sugar levels normal). currently, no effective drug treatment for nafld exists. there is increasing evidence that nafld may be a condition due to a problem with metabolism (the way your body uses energy). previous studies have shown that high glucose (sugar) levels may play an important role in the development of fatty liver disease. medications that decrease your natural glucose level may reduce the amount of fat in the liver and, therefore, might be useful in the treatment of nafld. metformin, a drug approved by the u.s. food and drug administration (fda) for use in patients with diabetes, has been shown to improve fatty liver in animals and in a small number of human beings.

Eligibility criteria:
inclusion criteria: * biopsy-proven nafld, determined within 12 months of study initiation exclusion criteria: * \> 20 grams of alcohol/day * impaired oral glucose tolerance test * known diagnosis of diabetes mellitus * hepatitis c infection * cirrhosis

Keywords: nonalcoholic fatty liver disease
a randomized, double-blind, parallel-group assessment of the safety and efficacy of telmisartan 40mg plus hydrochlorothiazide 12.5mg (micardis plus) in comparison with losartan 50mg plus hydrochlorothiazide 12.5mg in taiwanese patients with mild to moderate hypertension

Conditions: Hypertension

Summary: the primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (micardis plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference aiia combined with diuretic, in taiwanese patients with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: 1. mild to moderate hypertension as defined by a morning mean(\>95 and \ 140 and \<200mmhg. the mean dbp and sbp values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake. 2. male or female between 20 to 80 years old 3. ability to provide written informed consent. exclusion criteria: 1. patients are still taking more than three anti-hypertensives at the screening visit 2. pre-menopausal women 3. known or suspected secondary hypertension 4. mean sitting dbp\ 200mmhg at the end of placebo run-in phase 5. hepatic and/or renal dysfunction 6. known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant 7. known nyha functional class chronic heart failure (chf) iii, iv 8. unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months 9. post-transluminal coronary angioplasty(ptca) within the preceding three months 10. sustained ventricular tachycardia, atria fibrillation, second or third degree av block, vpc or apc (\>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator 11. hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve. 12. once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates 13. clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/l 14. clinically significant hyperkalemia as defined by serum potassium level \>5.5 mmol/l 15. non-insulin dependent dm poorly controlled whicih is defined as hba1c\>8% twice consecutively within 6 months and/or ac blood sugar\>180 mg/dl. 16. insulin dependent diabetes mellitus 17. chronic administration of oral anticoagulants and/or digoxin within the past 6 months. 18. known drug or alcohol dependency 19. administration of medication known to affect blood pressure, except medication allowed by the protocol 20. angioedema with ace inhibitors 21. use of nitrates
levofloxacin for the management of patients with abnormal prostate specific antigen (psa)

Conditions: Prostatic Hyperplasia; Prostatitis

Summary: multicentric, national, prospective, parallel group, controlled. the subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring


Eligibility criteria:
inclusion criteria: only subjects who meet all of the following criteria will be eligible to participate in this study: * male patients * age ≥ 45 years * suspected presence of prostate inflammatory foci, defined according to the following criteria: * psa ≥ 2.6 ng/ml and age ≥ 50 and \< 60 years (or ≥ 45 years if the patient has known family predisposition to carcinoma of the prostate) or, * psa ≥ 4.1 ng/ml and age ≥ 60 and \< 75 years, and * normal digito-rectal examination (dre) (see section 5.2), and normal urine test with dipstick and/or microscopy carried out within 5 days of the baseline visit * patients willing and able to provide their written informed consent and to comply with study procedures. * patients with luts/bph on watchful waiting or already under treatment with alpha-blockers or 5-ari (5-alpha reductase inhibitors) for at least 6 months will also be considered eligible to participate in the study. exclusion criteria: patients who meet any of the following criteria will not be eligible to participate in this study: * diagnosis of nih class i-iii prostatitis or clinical evidence of active acute urinary infection and/or known or suspected active bacterial infection at other sites; * diagnosis of prostate carcinoma (or pin or asaps) or prior radical prostatectomy or radiotherapy or other treatments for prostate cancer; * psa \> 20 ng/ml; * psa values (including high values) stable over time; * start of a pharmacological therapy with 5-ari in subjects with luts/bph; * permanent catheter; * prior treatment (within 4 weeks) with levofloxacin for genital-urinary infections; * known or suspected allergy to levofloxacin, including the excipients contained in the pharmacological preparation and/or confirmed tendency to photosensitivity reactions after fluoroquinolone therapy; * concomitant treatment with drugs not allowed in the study * reluctance to undergo prostate biopsy and/or risk of non-compliance; * history or current evidence of alcohol or drug abuse in the last 12 months; * history of any conditions that, in the opinion of the investigator, may confound the study results or create additional risks for the patient. * participation in any study of investigational or marketed drugs within 30 days before the baseline visit or during the study.

Keywords: diagnostic-therapeutic pathway psa dre levofloxacin
study to identify and characterize the bacteria causing acute otitis media episodes in young children in saudi arabia

Conditions: Infections, Streptococcal

Summary: the purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged ≥ 3 months to \< 5 years in saudi arabia.


Eligibility criteria:
inclusion criteria: a child will be eligible for inclusion if he/she meets the following criteria: * age: ≥ 3 months and \< 5 years at the time of enrolment. the subject becomes ineligible on the fifth birthday. * signs, symptoms, and conditions: i. one of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever and either ii. paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) or iii. spontaneous otorrhoea of less than 24 hours * onset of signs and symptoms of aom within 72 hours prior to diagnosis of aom by a physician. to be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment * written informed consent obtained from parent or guardian prior to study start. exclusion criteria: the following criteria should be checked at the time of study entry. if any apply, the child must not be included in the study. * hospitalised during the diagnosis of aom or during treatment, * otitis externa, or otitis media with effusion * presence of a transtympanic aerator * systemic antibiotic treatment received for a disease other than aom in the 72 hours prior to enrolment, * receiving antimicrobial prophylaxis for recurrent aom, * provision of antibiotic by paediatrician/ent specialist at the enrolment visit, prior to the sampling * patients on antibiotics for aom who are clinically improving.

Keywords: non-typeable haemophilus influenzae acute otitis media streptococcus pneumoniae etiology
a safety and efficacy evaluation of bli801 laxative in constipated adults

Conditions: Constipation

Summary: a pilot study to evaluate the safety and efficacy of multiple bli801 doses in constipated adults.


Eligibility criteria:
inclusion criteria: male or female subjects at least 18 years of age constipated, defined by rome definition: otherwise in good health, as determined by physical exam and medical history exclusion criteria: subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments subjects who are allergic to any bli801 component subjects currently taking narcotic analgesics or other medications known to cause constipation subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days subjects with an active history of drug or alcohol abuse
the effect of acupuncture treatment on sleep quality in post-stroke patients

Conditions: Stroke; Complementary

Summary: the aim of this study is to investigate the effectiveness and reliability of acupuncture treatment in patients experiencing impaired sleep quality after a stroke. additionally, the goal is to reduce the need for multiple medications and/or high-dose drug usage in the treatment of these complications in patients

the aim of this study is to evaluate the effect of acupuncture therapy on sleep quality in patients experiencing insomnia in the early post-stroke period. in this prospective, randomized controlled, single-blind study, 70 ischemic stroke patients undergoing inpatient rehabilitation were included. participants were randomly divided into two groups: the acupuncture group receiving acupuncture therapy and standard rehabilitation program. the control group receiving only the standard rehabilitation program. the acupuncture group received acupuncture treatment twice a week for 4 weeks. sleep quality was evaluated using the pittsburgh sleep quality index (psqi). the psqi scores were assessed three times at baseline, at the 4th week, and at the 8th week. the results of the study indicated that the acupuncture group demonstrated a significant improvement in sleep quality compared to the control group. significant differences were observed between the baseline psqi scores and the psqi scores at the 4th week in both the acupuncture and control groups (p: 0.000 and p: 0.008). the change between baseline and 8th-week psqi scores was also significant (p: 0.000 and p: 0.000). however, in the acupuncture group, the decrease in psqi scores was significantly greater compared to the control group. the addition of acupuncture therapy to standard treatment resulted in a significant improvement in sleep quality. additionally, the baseline psqi scores were found to be correlated with the severity of depression.this study suggests that acupuncture therapy can be an effective intervention for improving sleep quality in patients with early post-stroke insomnia.

Eligibility criteria:
inclusion criteria: * being between 18-80 years of age, * having a minimum of 2 and a maximum of 6 months elapsed since the ischemic stroke, -volunteering to participate in the study, * having a mini-mental test score above 17. exclusion criteria: * history of insomnia or depression before stroke, * psychiatric medication use, * psychiatric illness, aphasia, sleep apnea syndrome, * decompensated cardiac, renal, or hepatic insufficiency, pregnancy, * presence of infection in the areas where acupuncture would be applied.

Keywords: acupuncture sleep medicine stroke
penicillin prophylaxis in sickle cell disease (props)

Conditions: Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies; Infection (S. Pneumoniae); Pneumonia

Summary: to determine whether the regular daily administration of oral penicillin would reduce the incidence of documented infection due to streptococcus pneumoniae in children with sickle cell anemia.

background: for over 20 years children with sickle cell anemia have been known to have an increased susceptibility to severe bacterial infection, particularly due to streptococcus pneumoniae. meningitis, pneumonia and septicemia due to this organism have been recognized as the major causes of death for these children, with children under three years of age being at highest risk. the annual incidence of pneumococcal septicemia among young children with sickle cell anemia appears to have remained remarkably constant over the last two decades at approximately 10 percent. this illness can often be fulminant, progressing from the onset of fever to death in less than 12 hours, with a case fatality rate ranging as high as 35 percent. penicillin prophylaxis has been advocated as a preventive measure against severe pneumococcal infections in children with sickle cell anemia. one study had shown that the risk of pneumococcal infection in these children could be reduced by the use of parenteral penicillin. design narrative: phase i was a multi-center, randomized, double-blind, placebo-controlled trial. one hundred and five patients were assigned to the penicillin group and 110 to placebo. the primary endpoint was a documented severe infection due to s. pneumoniae. the secondary endpoint was a severe infection due to an organism other than s. pneumoniae. because data were not available to define the age at which prophylactic penicillin could be safely discontinued, the nhlbi launched phase ii of the prophylactic penicillin study beginning in 1987. recruitment ended in august, 1993. the clinical phase of phase ii ended in august, 1994. phase ii was a multi-center randomized trial to evaluate the hazards of discontinuing daily oral penicillin at the age of five years. within three months of their fifth birthdays, all children were randomized to continue oral penicillin prophylaxis or to stop prophylaxis. each child was followed for a minimum of two years. the primary endpoint was a comparison of documented pneumococcal infection in children continuing penicillin after five years of age versus children whose prophylaxis was stopped at five years of age. ancillary studies conducted in subsets of patients included: the prevalence of colonization of the nasopharynx with antibiotic resistant microorangisms; and the relationship of antibody response to pneumococcal vaccination to the incidence of pneumococcal sepsis in this patient population.

Eligibility criteria:
in the phase i trial, black children with sickle cell anemia aged 3 months to 3 years. in the phase ii trial, children with sickle cell anemia aged five years 3 months of age and younger who had received prophylactic penicillin for at least two yea